German Offenlegungsschrift 199 03 693 and EP 0952215 A, which are incorporated herein by reference), discloses a protease for activating coagulation factor VII, a process for isolating it, detecting it and inactivating it, and medicinal preparations which comprise this protease or its proenzyme, which is the non-activated form of the protease. It is also reported therein that this protease and its proenzyme suffer, after enrichment or isolation, a rapid loss of activity, which was observed in a solution containing 20 mM Tris, 0.15 mM NaCI at a pH of 7.5. For stabilization, it proposed a preparation which was prepared
a) with addition of one or more amino acids in an amount of 0.01 mol/l, preferably more than 0.05 mol/l; and/or
b) with addition of a sugar or of a combination of various sugars with a total concentration of more than 0.05 g/ml, preferably more than 0.2 g/ml and/or
c) with addition of one or more substances which are able to complex calcium ions, such as citrate, oxalate, ethylenediaminetetraacetic acid etc.
The preparation was moreover adjusted to a pH range from 3.5 to 8.0, preferably to a pH range from 4.0 to 6.8.
Although use of the aforementioned agents achieved considerable success in stabilization, it has proved necessary to look for other stabilizers and stabilizer mixtures which are suitable for use in liquid preparations of said protease and its proenzyme and ensure that such preparations can be stored over prolonged periods, which may amount to several months, without seeing any loss of activity or other changes in the product.